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OVERVIEW

EXSCEL evaluated the cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes.

design

Randomised, placebo-controlled global clinical trial performed in people with type 2 diabetes diabetes, with or without previous cardiovascular disease. In total, 14,752 patients were enrolled between 18th June 2010 and 16th September 2015. EXSCEL was coordinated jointly by the DTU and the Duke Clinical Research Institute (DCRI) and conducted in 687 sites from 35 countries.

RESULTS

The results of EXSCEL were reported at the 2017 meeting of the EASD. It met its primary safety endpoint of non-inferiority for the primary composite cardiovascular endpoint (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). The corresponding efficacy endpoint analysed for superiority did not reach statistical significance, although a pre-specified analysis suggested all-cause mortality was lower with exenatide compared to placebo. The primary results paper is available here.

Manuscript proposals

The EXSCEL Publications Committee are happy to review proposals for potential new manuscripts. Proposals should be submitted on an EXSCEL Trial Topic Request Form emailed to peter.hoffmann@duke.edu

Joint chairs

Adrian Hernandez (Previously Robert Califf)
Rury Holman

Sponsor

Amylin Pharmaceuticals, a wholly owned subsidiary of AstraZeneca

Funder

AstraZeneca

Reference numbers

NCT01144338
EudraCT 2010-021069-63

EXSCEL PUBLICATIONS